Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
ConditionMyopia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-11
SponsorLaboratoires Thea
About this trial
Axial myopia is a type of nearsightedness that happens when the eye is too long from front to back. This causes distant vision to be blurry. Axial myopia tends to start during childhood and worsens over time (as the eyes continue to grow longer). This can lead to serious eye-related conditions later in life. The aim of T10430 treatment is to stop or slow this progression during childhood and therefore, prevent more serious complications. Animal studies using drugs with a similar mechanism of action as T10430 have demonstrated positive safety results. This study aims to better understand the safety and potential effectiveness of T10430 in children with axial myopia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Informed consent signed and dated.
- Male or female participant between ≥ 6 and < 12 years old.
- Spherical equivalent refractive error (SER) of at least -1.00D and no more than -6.00D in each eye as measured by cycloplegic autorefraction.
- IOP < 21mmHg in each eye.
Disqualifiers
Known intolerance to administration of eye drops.
Astigmatism > 1.50D as measured by cycloplegic autorefraction.
Anisometropia ≥ 1.50D as measured by cycloplegic autorefraction.
Current or history of amblyopia or manifest strabismus including intermittent tropia.
Trial design
Design model
Parallel
Treatments tested in this trial
T10430 lower dose
DrugThe participant will be instilled 1 drop of the T10430 in the conjunctival cul-de-sac of each eye, once daily, at 20h00 (±2 hours) from Day 1 to the day before the End of treatment visit (Visit #4).
T10430 middle dose
DrugThe participant will be instilled 1 drop of the T10430 in the conjunctival cul-de-sac of each eye, once daily, at 20h00 (±2 hours) from Day 1 to the day before the End of treatment visit (Visit #4).
T10430 higher dose
DrugThe participant will be instilled 1 drop of the T10430 in the conjunctival cul-de-sac of each eye, once daily, at 20h00 (±2 hours) from Day 1 to the day before the End of treatment visit (Visit #4).
Vehicle
DrugThe participant will be instilled 1 drop of the vehicle in the conjunctival cul-de-sac of each eye, once daily, at 20h00 (±2 hours) from Day 1 to the day before the End of treatment visit (Visit #4).
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: T10430 lower doseExperimental treatment 1 intervention
Group B: T10430 middle doseExperimental treatment 1 intervention
Group C: T10430 higher doseExperimental treatment 1 intervention
Group D: VehiclePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Measure of the occurrence of treatment-emergent adverse events (TEAEs).
Frequency of ocular treatment-emergent adverse events (TEAEs), serious ocular TEAEs, IMP-related ocular TEAEs, ocular TEAEs leading to premature IMP discontinuation by system organ class (SOC) and preferred term (PT).
Time frame
From the time the participant signs the assent and their legual guardian the informed consent and throughout the entire study: up to approximately 60 weeks, including a maximum treatment period of 56 weeks and a 4 weeks follow-up period.Secondary outcomes
1
Effectiveness of T10430 on Axial Length Change
Measurement of axial length changes in mm of the eyes (from the front \[cornea\] to the back \[the retina\]).
Time frame
From the start of treatment to 6 months and 12 months of treatment.2
Effectiveness of T10430 on Spherical Equivalent Refraction
Measurement of change in the focusing power of the eye, called spherical equivalent refraction, in D (Diopter).
Time frame
From the start of treatment to 6 months and 12 months of treatment.3
Assessment and collection of T10430 Safety events during Physical and Eye examinations
Study doctors will record and assess any health events experienced by participants during physical and eye examinations.
Time frame
From the time the participant signs the assent and their legual guardian the informed consent and throughout the entire study: up to approximately 60 weeks, including a maximum treatment period of 56 weeks and a 4 weeks follow-up period.Sponsors and contacts
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Source ClinicalTrials.gov